- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01107223
Long Term Effect of General Practitioner Education on Antibiotic Prescribing (PAAIR2)
April 19, 2010 updated by: Henri Mondor University Hospital
Long Term Effect of General Practitioner Education on Antibiotic Prescribing: a Large Scale Randomized Study
Respiratory tract infections are the most common indication for antibiotic prescribing in primary care.
Several studies have shown a strong relationship between antibiotic use and bacterial resistance.
The aim of this trial was to assess the long-term effect of a continuous education program on general practitioners antibiotic prescribing behaviour.
170 physicians were included in this study.
Physicians randomized in the education group attended a two days seminar focused on evidence-based guidelines on antibiotic use in respiratory tract infections.
The intervention was limited at physicians level and did not target the patients.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Créteil, France, 94000
- Henri Mondor Hospital, department of general practice
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- General practitioners practicing in three departments of the Parisian area in France
- General practitioners attending a two days didactic educational meeting on evidence-based guidelines for diagnosis and treatment of acute respiratory tract infection.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control
|
GPs assigned to control group received no specific recommendations on antibiotic prescription.
|
Experimental: Training to antibiotic prescription
Physicians randomized in the education group attended a two days seminar focussed on evidence-based guidelines on antibiotic use in respiratory tract infections.
|
GPs assigned to the intervention group attended a two days didactic educational meeting on evidence-based guidelines for diagnosis and treatment of acute respiratory tract infection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the percentage of prescriptions containing an antibiotic between control and intervention groups (seminar on the treatment of respiratory tract infections).
Time Frame: Effect of the intervention 4 to 6 months after the educational training.
|
All prescriptions written by all general practitioners enrolled in the study were extracted each year from the French National Health System database.
All data were compared to 2004 (baseline).
Education group GPs attended a two-day seminar presenting evidence-based guidelines on antibiotic prescription in respiratory tract infections.
The change (compared to baseline) in the percentage of prescriptions containing an antibiotic (antibiotic prescription rates) was compared between control and intervention groups.
|
Effect of the intervention 4 to 6 months after the educational training.
|
Change in the cost of antibiotic prescription between control and intervention groups (seminar on the treatment of respiratory tract infections).
Time Frame: Effect of the intervention 4 to 6 months after the educational training.
|
All prescriptions written by all general practitioners enrolled in the study were extracted each year from the French National Health System database.
All data were compared to 2004 (baseline).
Education group GPs attended a two-day seminar presenting evidence-based guidelines on antibiotic prescription in respiratory tract infections.
The change (compared to baseline) in the cost of antibiotic prescription was compared between control and intervention groups.
|
Effect of the intervention 4 to 6 months after the educational training.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Long term antibiotic prescription rates
Time Frame: Effect of the intervention 28 to 30 months after the educational training.
|
Long term change in the percentage of antibiotic prescriptions between both groups
|
Effect of the intervention 28 to 30 months after the educational training.
|
Long term antibiotic cost.
Time Frame: Effect of the intervention 28 to 30 months after the educational training.
|
Long term change in the cost of antibiotic prescriptions between both groups
|
Effect of the intervention 28 to 30 months after the educational training.
|
Symptomatic drug prescription rates
Time Frame: Effect of the intervention 28 to 30 months after the educational training.
|
Prescription rates of symptomatic drug for respiratory infections between both groups
|
Effect of the intervention 28 to 30 months after the educational training.
|
Symptomatic drug cost.
Time Frame: Effect of the intervention 28 to 30 months after the educational training.
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Cost of symptomatic drug between both groups
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Effect of the intervention 28 to 30 months after the educational training.
|
Effect of patient age.
Time Frame: Effect of the intervention 28 to 30 months after the educational training.
|
Effect of patient age on antibiotic prescription between both groups
|
Effect of the intervention 28 to 30 months after the educational training.
|
Effect of a seminar on problem-solving strategy on prescriptions.
Time Frame: Effect of the intervention 28 to 30 months after the educational training.
|
A second randomization was performed among the intervention group.
In one subgroup, GPs attended an additional seminar on problem-solving strategies.
Antibiotic prescription rates were compared between controls, evidence-based and problem-solving subgroups.
Antibiotic cost was also compared between the both subgroups
|
Effect of the intervention 28 to 30 months after the educational training.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Clause Attali, MD, Henri Mondor University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
April 1, 2009
Study Completion (Anticipated)
April 1, 2010
Study Registration Dates
First Submitted
March 4, 2010
First Submitted That Met QC Criteria
April 19, 2010
First Posted (Estimate)
April 20, 2010
Study Record Updates
Last Update Posted (Estimate)
April 20, 2010
Last Update Submitted That Met QC Criteria
April 19, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAAIR2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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